BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Affinity CP Adapter

    Reg #: 3003661577 · FEI: 3003661577 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KLUGE DESIGN INC.
    Registration Number
    3003661577
    FEI Number
    3003661577
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14150 Northdale Blvd
    City
    Rogers
    State
    MN
    ZIP
    55374
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132712

    Owner / Operator

    Firm Name
    Kluge Design LLC
    Operator Number
    10030771
    Address
    14150 Northdale Blvd
    City
    Rogers
    State
    MN
    Postal Code
    55374
    Country
    US
    Correspondent
    Erik Kariniemi

    Products

    Device Name Product Code
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM

    Proprietary Names

    Affinity CP Adapter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)